In many clinical situations, it is extremely desirable to be able to obtain continuous measurements of tissue oxygenation. While it is desirable to have an absolute measure of OS, it is often sufficient to measure relative changes in the blood oxygen saturation. For example, in the operating room, the physician is typically concerned only with significant changes in the patient's OS, and is less concerned with the measurement of absolute OS. In this situation, a noninvasive oximeter which is capable of detecting significant changes in the blood oxygen content would be especially useful.
It is well known that hemoglobin and oxyhemoglobin have different optical absorption spectra and that this difference in absorption spectra can be used as a basis for an optical oximeter. Most of the currently available oximeters using optical methods to determine blood oxygen saturation are based on transmission oximetry. These devices operate by transmitting light through an appendage such as a finger or an earlobe. By comparing the characteristics of the light transmitted into one side of the appendage with that detected on the opposite side, it is possible to compute oxygen concentrations. The main disadvantage of transmission oximetry is that it can only be used on portions of the body which are thin enough to allow passage of light. There has been considerable interest in recent years in the development of an oximeter which is capable of using reflected light to measure blood oxygen saturation. A reflectance oximeter would be especially useful for measuring blood oxygen saturation in portions of the patient's body which are not well suited to transmission measurements.
Various methods and apparati for utilizing the optical properties of blood to measure blood oxygen saturation have been shown in the patent literature. Representative devices for utilizing the transmission method of oximetry have been disclosed in U.S. Pat. Nos. 4,586,513; 4,446,871; 4,407,290; 4,226,554; 4,167,331; and 3,998,550. In addition, reflectance oximetry devices and techniques are shown generally in U.S. Pat. Nos. 4,447,150; 4,086,915; and 3,825,342.
A theoretical discussion of a basis for the design of a reflectance oximeter is contained in "Theory and Development of a Transcutaneous Reflectance Oximeter System for Noninvasive Measurements of Arterial Oxygen Saturation," by Yitzhak Mendelson (Published Doctoral Dissertation), No. 8329355, University Microfilms, Ann Arbor, Mich. (1983). A theoretical discussion of the optical properties of blood is found in "Optical Scattering in Blood," by Narayanan R. Pisharoty, (Published Doctoral Dissertation), No. 7124861, University Microfilms, Ann Arbor, Mich. (1971).
Numerous other works have disclosed theoretical approaches for analyzing the behavior of light in blood and other materials. The following is a brief list of some of the most relevant of these references: "New Contributions to the Optics of Intensely Light-Scattering Materials, Part 1," by Paul Kubelka, Journal of the Optical Society of America, Volume 38, No. 5, May 1948; "Optical Transmission and Reflection by Blood," by R. J. Zdrojkowski and N. R. Pisharoty, IEEE Transactions on Biomedical Engineering, Vol. BME-17, No. 2, April 1970; and "Optical Diffusion in Blood," by Curtis C. Johnson, IEEE Transactions on Biomedical Engineering, Vol. BME-17, No. 2, April 1970.
One of the difficulties which has been encountered in the use of optical oximeters is the calibration of such devices to provide accurate readings at lower levels of oxygen saturation. In particular, difficulties have been encountered in the use of optical oximeters to measure oxygen saturations below 90%. The noninvasive reflectance oximeter provided by the present invention overcomes these difficulties, as described in greater detail below.